Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

NCT03155061 — Phase 1, Active not recruiting, 183 participants, Ono Pharmaceutical Co., Ltd.
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Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

RegistryNCT03155061
StatusActive not recruiting
PhasePhase 1
Study typeInterventional; non randomized, sequential, masking: none, treatment
Enrollment183 (Estimated)
SponsorOno Pharmaceutical Co., Ltd. (Industry)
ConditionsAdvanced or Metastatic Solid Tumors
InterventionsONO-4578, ONO-4538 (Drug)
Datesstart 2017-04-19, primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2017-05-16, last updated 2026-09-04
Locations22 sites in Japan

Related Papers Related Patents Related Grants Related Experts
All trials for Advanced or Metastatic Solid Tumors All trials of ONO-4578 All trials of ONO-4538

-Summary

The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.

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+Arms and interventions

ArmTypeInterventionsDescription
Part A (Dose Escalation Part): ONO-4578 monotherapyExperimentalDrug: ONO-4578ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
Part B: ONO-4578 in combination with ONO-4538ExperimentalDrug: ONO-4578; Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
Part C (Expansion Part): ONO-4578 in combination with ONO-4538ExperimentalDrug: ONO-4578; Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
Part D (Expansion Part): ONO-4578 in combination with ONO-4538ExperimentalDrug: ONO-4578; Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
  • ONO-4578 (Drug): ONO-4578 specified dose on specified days
  • ONO-4538 (Drug): ONO-4538 specified dose on specified days

+Outcome measures

Primary outcomes

  • Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) [Through study completion, an average of 1 year]

Secondary outcomes

  • Maximum observed serum concentration(Cmax) [Up to Cycle 1 (each cycle is 28 days)]
  • Area Under the blood concentration-time Curve(AUC) [Up to Cycle 1 (each cycle is 28 days)]
  • Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 [Up to Cycle 1 (each cycle is 28 days)]

+Eligibility

Sex: All, ages: 20 Years to any

Inclusion Criteria:

* Advanced or metastatic solid tumors (Part A, B)
* Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
* Unresectable, advanced or recurrent colorectal cancer(Part D)
* Life expectancy of at least 3 months
* Patients with ECOG performance status 0 or 1

Exclusion Criteria:

* Patients with severe complication
* Patients with multiple primary cancers

+Locations (22)

FacilityCityCountryStatus
Aichi Clinical Site 1Nagoya, Aichi-kenJapan
Aichi Clinical Site 2Toyoake, Aichi-kenJapan
Chiba Clinical Site 1Kashiwa, ChibaJapan
Ehime Clinical Site1Matsuyama, EhimeJapan
Fukuoka Clinical Site 1Fukuoka, FukuokaJapan
Fukuoka Clinical Site 2Fukuoka, FukuokaJapan
Gunma Clinical Site 1Ōta, GunmaJapan
Hokkaido Clinical Site 1Sapporo, HokkaidoJapan
Iwate Clinical Site 1Yahaba-cho, IwateJapan
Kanagawa Clinical Site 2Sagamihara, KanagawaJapan
Kanagawa Clinical Site 1Yokohama, KanagawaJapan
Osaka Clinical Site 2Hirakata, OsakaJapan
Osaka Clinical Site 1Osaka, OsakaJapan
Osaka Clinical Site 3Sakai, OsakaJapan
Osaka Clinical Site 4Takatsuki, OsakaJapan
Saitama Clinical Site 2Hidaka, SaitamaJapan
Saitama Clinical Site 1Ina-machi, SaitamaJapan
Shizuoka Clinical Site 1Nagaizumi-Cho, ShizuokaJapan
Tokyo Clinical Site 1Chuo-ku, TokyoJapan
Tokyo Clinical Site 4Itabashi-ku, TokyoJapan
Tokyo Clinical Site 2Koto-ku, TokyoJapan
Tokyo Clinical Site 3Shinjyuku-ku, TokyoJapan

+Publications

  • Results publication: Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6. PMID 40618725
  • Results publication: Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4. PMID 36082616

+Investigators